FDA has released, and posted, briefing documents relating to the 12.8.11 joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. These documents provide a some insight into the anticipated dialogue and discourse the hearings are expected to generate. The FDA released the documents on 12.6.11 and they are available at http://www.fda.gov/
The Washington Post reports that “FDA Say YAZ and Relate Birth Control Pills Should Carry More Info About Risk of Blood Clots” and cites the briefing documents. In sum, they quote an excerpt from the FDA’s background documents which concludes “[w]e believe that, because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility“. FDA’s review is also noted as concluding that conflicting studies cannot be easily reconciled.
MedPage Today, Washington Correspondent, Emily P. Walker, notes in “BAYER Charged with Burying Negative VTE Data for Yasmin” that former FDA Commissioner, David Kessler, M.D., has been hired as an expert witness for women with lawsuits pending against the manufacturer, BAYER. MedPage qoutes Kessler as stating:
- “By failing to disclose all thromboembolic event risk information and marketing YAZ and YASMIN off-label, BAYER needlessly explosed large numbers of women to risks of serious or fatal thromboembolic events“.
- “In my opinion, BAYER had a duty to present a full and balanced view of all the data and analysis concerning YASMIN to the FDA and healthcare professionals and failed to do so“.
- “It appears, based on the information that I have reviewed, and it is my opinion, that BAYER presented a selective view of the data, and that presentation obscured the potential risks associated with YASMIN“.
- “BAYER engaged in extensive, systematic off-label promotion of YASMIN and YAZ for PMS, in violation of FDA law and regulations, thereby unnecessarily exposing large numbers of women to risk of thrombembolic events in violation of state law duties“.
Kessler’s opinions and statements illustrate the need for public scrutiny, as well as continued, and vigilant, regulatory intervention of DRSP (DROSPIRENONE) containing birth control. (Visit “YAZ DRSP & FDA HISTORY 2000-2011″ on this site for a chronological history of the pills and FDA action)
In the face of new science, FDA hearings and emerging scientific evidence, BAYER continues to rely upon prior studies to defend the safety and effectiveness of the DRSP (DROSPIRENONE) family of birth control. Despite mutiple studies, since 2009, as well as FDA’s own study that concluded the pills present a higher blood clot risk than other available hormonal contraceptives, BAYER continues to claim the new studies are flawed or unreliable, thus giving rise for current scientific debate and evaluation.
Regardless of the statistical likelihood of a girl or woman experiencing a blood clot noone should look past the statements of former FDA Commissioner Kessler and his evaluation of confidential and proprietary documents. Girls and women that have taken any DRSP (DROSPIRENONE) pill, YASMIN, YAZ, BEYAZ, SAFYRAL and their generics, have to consider whether or not they were adequately informed at the time of potential risks. The pills have now been available for nearly a decade and the warning labels have only been updated to reflect increased warnings in the past 18 months. FDA hearings may only result in yet another modification to the warning. What does that do for the Generation of Women that took the pills and suffered injuries over the past decade? What does that do for women, or girls, that were injured and did not find lawyers prior to 2009 when studies began to emerge calling the manufacturer’s labeling into question? What does it do for those who have sought legal representation and been told the “Statute of Limitations“, “Statute of Repose” or legal time frame within which to seek a legal remedy has expired?
Kessler’s statements substantiate that they were knowingly exposed to risks, regardless of whether the suffered any harm. Similarly, medical providers have to also question the information that was disclosed to them to aid in making informed decisions with patients. Based upon the legacy DRSP (DROSPIRENONE) pills have already left in the past decade, what future, if any the pills have after 12.8.11 remains to be seen. We will report and monitor on any developments following the hearings. You may contact the sponsor of this site with any questions, or if you have suffered injuries from DRSP (DROSPIRENONE) for a FREE CASE EVALUATION. The sponsor of this site is:
Gabriel F. Zambrano
Gabriel F. Zambrano, P.A.
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